Status:
COMPLETED
Lorazepam Sedation for Critically Ill Children
Lead Sponsor:
The Emmes Company, LLC
Collaborating Sponsors:
Case Western Reserve University
Conditions:
Critical Illness
Eligibility:
All Genders
1-18 years
Phase:
PHASE2
PHASE3
Brief Summary
This clinical trial is being performed under the Best Pharmaceuticals for Children Act, signed into law in 2002 in order to improve pediatric labeling for off-patent drugs. The purpose of this study i...
Detailed Description
Lorazepam is used clinically for sedation of mechanically ventilated children, but has not been approved by the FDA for this indication in children. The purpose of this study, in response to the Writt...
Eligibility Criteria
Inclusion
- Males or females from full term birth (at least 38 weeks post conceptual age) through 18 years
- Patients must be intubated and mechanically ventilated in the PICU less than or equal to 24 hr
- Patients in whom the use of neuromuscular blocking agents would normally NOT be expected to be used.
- Patient's parent or guardian has signed a consent form prior to initiation of study procedures
- Patients with cardiac, renal, or hepatic dysfunction will be actively sought
Exclusion
- Life expectancy \< 48 hr
- Expected duration of sedation \< 48 hr
- Patient with history of hypersensitivity to any component of lorazepam, midazolam, fentanyl, thiopental
- Females pregnant or breast feeding
- Patient requires sedatives or analgesics other than study drug
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
179 Patients enrolled
Trial Details
Trial ID
NCT00109395
Start Date
September 1 2004
End Date
September 1 2007
Last Update
March 20 2023
Active Locations (1)
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1
Case Western Reserve University
Cleveland, Ohio, United States, 44106-6010